NCT07027982已完成1 期
An Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of Diluted vs. Undiluted Intravenous DA-5217 in Healthy Adult Subjects
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- AUClast
研究概览
简要总结
This study will evaluate the pharmacokinetics and safety of Diluted and Undiluted Intravenous DA-5217 in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male or female, 19 years to 45 years
- •Weighing 50 kg or more, with a body mass index (BMI) of 18.5 kg/m2 to 29.9kg/m2
- •The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate and complied with the precautions.
排除标准
- •The subjects with existing or previous conditions that may influence the pharmacokinetics of drugs
- •The subjects hypersensitive to any of the Investigational Product components or other drug components
- •The subjects with clinically significant active chronic conditions
- •The subjects with a positive urine drug test result or a history of drug abuse or dependence.
- •The subjects who are pregnant or lactating
研究组 & 干预措施
Sequence 1
Experimental
干预措施: Diluted Intravenous DA-5217 (Drug)
Sequence 1
Experimental
干预措施: Undiluted Intravenous DA-5217 (Drug)
Sequence 2
Experimental
干预措施: Diluted Intravenous DA-5217 (Drug)
Sequence 2
Experimental
干预措施: Undiluted Intravenous DA-5217 (Drug)
结局指标
主要结局
AUClast
时间窗: 0~24hours
Area under the plasma concentration-time curve from time zero to time the last quantifiable time
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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